Anatomy of the SPL File

A

B

C

D

Each business location (e.g., headquarters, branch, subsidiary, establishment, importer, US agent) has its own unique site specific DUNS Number.

E

Effective Time

The effective time provides a date reference to the SPL version.
The date includes the year, month and day using the format yyyymmdd.

F

G

H

I

ID Root

The id root uniquely identifies a specific SPL file.
Each new version of an SPL file has a new id root.
The id root is a Globally Unique Identifier (GUID).

J

K

L

Labeler Name

The labeler is the registrant or private label distributor requesting the NDC Labeler Code. The information includes the labeler name and DUNS Number.1

M

N

O

P

Q

R

S

Setid Root

The setId root uniquely identifies a group of versions of an SPL file. When an SPL file changes a new id root is assigned to the new SPL file but the setId root in the original SPL file is used. Like the id root, the setId root is a GUID.

Source NDC

The source code is NDC Product Code for a Source Drug Repacked or Relabeled
Repackers and relabelers may submit the NDC Product Code for the source drug that is repacked or relabeled to reference previously submitted manufacturing establishment information.

T

Type of Document

U

V

Version Number

The version number provides an order for different versions of an SPL file.
The version number is a whole number greater than zero.
The version number is increased with each change.